Spinal Cord Injury Registry - North American Clinical Trials Network

Study acronym: NACTN
StatusRecruiting
PhaseNot specified
Started

Record status This record was last updated September 24, 2020 (before its estimated July 2025 completion). Its status may not reflect the trial's current state.

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Record History

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  1. Minor Study sites: 12 to 14
    • Study description expanded, about 7 words
    • Collaborators: 13 to 15
    • Study title expanded, about 4 words
    v22
  2. Notable Primary completion date: Jul 2020 to Jul 2025
    • Study completion date: Jul 2023 to Jul 2028
    • Site contacts updated at 5 of 12 sites
    • Collaborators revised (13)
    v21
  3. Minor Interventions: No treatment (Other) to No Treatment Given (Other)v20 Show 5 more changesShow less
    • Eligibility criteria expanded, about 20 words
    • Study description expanded, about 11 words
    • Study sites revised (12)
    • Collaborators revised (13)
    • Study title shortened, about 8 words
  4. Re-verified, no change to tracked fieldsv19
  5. Minor Study sites: 11 to 12
    • Eligibility criteria shortened, about 1 word
    • Study description expanded, about 3 words
    v18
Show 16 earlier versionsHide 16 earlier versions
  1. Minor Interventions: None other than standard of care for spinal cord injury (Other) to No treatment (Other)
    • Site details revised at 4 of 11 sites
    • Collaborators: 12 to 13
    v17
  2. Minor Site contacts updated at 2 of 11 sites
    • Study title expanded, about 9 words
    v16
  3. Notable Enrollment target: 500 to 1500v15 Show 9 more changesShow less
    • Primary completion date: Jul 2017 to Jul 2020
    • Primary endpoint revised
    • Study sites: 10 to 11
    • Study completion date: Jul 2019 to Jul 2023
    • Interventions: None other than standard of care for spinal cord injury (Other)
    • Study description expanded, about 33 words
    • Collaborators: 11 to 12
    • Study title shortened, about 7 words
    • Eligibility criteria expanded, about 3 words
  4. Notable Lead sponsor: The Methodist Hospital Research Institute to Robert G. Grossman, MDv14 Show 6 more changesShow less
    • Primary completion date: Jul 2012 to Jul 2017
    • Study sites: 9 to 10
    • Study completion date: Jul 2015 to Jul 2019
    • Study description expanded, about 10 words
    • Collaborators: 9 to 11
    • Eligibility criteria shortened, about 1 word
  5. Minor Study completion date: Jul 2013 to Jul 2015
    • Site contacts updated at 7 of 9 sites
    v13
  6. Notable Primary completion date: Jul 2011 to Jul 2012
    • Study completion date: Jul 2012 to Jul 2013
    • Study description expanded, about 9 words
    • Site details revised at 5 of 9 sites
    v12
  7. Minor Site contacts updated at 1 of 9 sitesv11
  8. Notable Enrollment target: 200 to 500v10 Show 4 more changesShow less
    • Primary completion date: Jul 2009 to Jul 2011
    • Study sites: 8 to 9
    • Start date: Jun 2005 to Jul 2005
    • Collaborators: 7 to 9
  9. Minor Enrollment target: 140 to 200v9 Show 7 more changesShow less
    • Study sites: 7 to 8
    • Primary completion date: Jul 2009
    • Study completion date: Jul 2012
    • Interventions: neurological exams and data on standard of care will be collected (Procedure) to not stated
    • Eligibility criteria shortened, about 15 words
    • Study arms: 0 to 1
    • Study title expanded, about 3 words
  10. Minor Site contacts updated at 2 of 7 sitesv8
  11. Re-verified, no change to tracked fieldsv7
  12. Minor Enrollment target: 100 to 140v6 Show 4 more changesShow less
    • Study sites: 6 to 7
    • Study description shortened, about 113 words
    • Collaborators: 6 to 7
    • Eligibility criteria shortened, about 4 words
  13. Minor Study sites: 5 to 6
    • Collaborators: 5 to 6
    • Study description expanded, about 4 words
    v5
  14. Minor Study description shortened, about 24 wordsv4 Show 4 more changesShow less
    • Site details revised at 3 of 5 sites
    • Collaborators: 2 to 5
    • Eligibility criteria shortened, about 1 word
    • Study title shortened, about 3 words
  15. Minor Site contacts updated at 2 of 5 sitesv3
  16. Notable Lead sponsor: The University of Texas Health Science Center, Houston to The Methodist Hospital Research Institute
    • Collaborators: 1 to 2
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The NACTN Spinal Cord Injury Registry is a network of clinical centers collecting de-identified data from patients admitted through the Emergency Department of a NACTN center at the time of injury with an initial (first time) spinal cord injury (SCI). Information will be collected on the natural history of SCI and course of treatment through the first 12 months from the date of injury or long as medically indicated. Data collected includes imaging information from CT or MRI scans, neurological and general medical outcome and rehabilitation evaluation. No intervention is given other than standard of care for spinal cord injury, intensive monitoring and frequent follow up care.
Trial Details
NCT Number NCT00178724
Lead Sponsor Robert G. Grossman, MD
Collaborators: Christopher Reeve Paralysis Foundation, The Methodist Hospital Research Institute, The University of Texas Health Science Center, Houston, University of Virginia, University of Louisville, University of Toronto, University of Maryland, Baltimore, Walter Reed National Military Medical Center, Thomas Jefferson University, University of Miami, Brooke Army Medical Center, Louisiana State University Health Sciences Center in New Orleans, Vanderbilt University Medical Center, Medical College of Wisconsin, Duke University
Conditions
(from sponsor)
Spinal Cord Injury
Related terms Paralysis, Spinal Cord Injuries
Enrollment 1,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov